TerminatedPhase 4

Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH)

Stopped: no more inclusions

France10 participantsStarted 2008-01

Plain-language summary

Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.

Who can participate

Age range4 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prepubertal age * Prepubertal characteristics * Non GH deficient * Short children (height \< -2.5 SDS) * Born SGA (birth height \< -2 SDS) * Parental height adjusted (\< -1 DS) * No rhGH treatment before inclusion Exclusion Criteria: * ALLERY to rhGH or excipients * Small height etiologies * Cancer or cancer treatment ongoing * Drugs interference with growth * Mental impairment * Hypertrophic cardiopathy impairment * Hypertension not under controlled * Intra cranial hypertension not controlled * Diabetes and hyperglycaemia without diabetes * Dyslipidemia * Hepatitis * Kidney failure * Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome) * No social security * State of health in worst conditions after cardiac surgery, polytraumatism

What they're measuring

Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA

Timeframe: every three months during twenty seven months

Trial details

NCT IDNCT00597480

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01